This policy paper, published by the Department of Health and Social Care, provides an update on the UK Government’s progress in implementing the recommendations of the Independent Medicines and Medical Devices Safety (IMMDS) Review, sometimes referred to as the Cumberlege Review.
The IMMDS Review examined the response of the healthcare system in England to the harmful side effects of three medical interventions: Hormone pregnancy tests, sodium valproate and pelvic mesh implants. These interventions had resulted in a truly shocking degree of avoidable harm to patients over a period of decades, with the Review describing the healthcare system’s response to this as ‘disjointed, siloed, unresponsive and defensive’.
In this report, the Government provides a progress update on the implementation of the Review’s recommendations, which is summarised below:
Recommendation 1 - The government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by primodos, sodium valproate and pelvic mesh.
Progress update - Complete. On 9 July 2020, the day after publication of the review, the Government issued an unreserved apology on behalf of the healthcare system to the women affected, as well as their children and their families, for the time the system took to listen and respond.
Recommendation 2 - The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility.
Progress update - Complete. The Government appointed Dr Henrietta Hughes as the Patient Safety Commissioner for England on 12 July 2022.
Recommendation 3 - A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries.
Progress update - The Government did not accept recommendation 3.
Recommendation 4 - Separate schemes should be set up for each intervention – HPTs (hormone pregnancy tests), valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
Progress update - The Government did not accept recommendation 4. In this report they point to NHS Resolution having now launched two claims gateways on their website to provide further support to patients who may wish to bring a clinical negligence claim in relation to pelvic mesh and sodium valproate.
Recommendation 5 - Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.
Progress update - Complete for specialist mesh centres. There are now nine specialist centres in operation in England. They state that this ensures that women in every region have access to these services and note that each mesh centre is led by a multidisciplinary team to ensure patients get access to the specialist care and treatment that they need, including pain management and psychological support.
Ongoing for medicines in pregnancy. They state that their view was that a network of new specialist centres is not the most effective way forward to help those adversely affected by medicines taken during pregnancy. The report notes that NHS England has instead taken forward work to improve care pathways for children and families adversely affected by medicines in pregnancy.
Ongoing for sodium valproate. The report states that the MHRA is introducing stronger regulatory measures to continue to reduce the number of pregnancies exposed to sodium valproate, including new patients under 55 years of age needing two specialists to document that no other medicine is effective or tolerated. It notes that work continues to improve compliance with regulatory measures, with the MHRA and NHS Digital establishing the Medicines and Pregnancy Registry to track NHS prescriptions of valproate in girls and women of childbearing age in England. In 2022 to 2023, an audit will be carried out by pharmacies to measure adherence to MHRA regulations.
Recommendation 6 - The MHRA needs substantial revision, particularly in relation to adverse event reporting and medical device regulation.
Progress update - Ongoing. They state that the MHRA has embarked upon an ambitious organisation-wide transformation to ensure it becomes a progressive and responsive patient-focused regulator of medical products. It notes that the Agency has been establishing a new organisational structure that improves how it listens and responds to patients and the public, developing a more responsive system for reporting adverse incidents, and strengthening the evidence to support timely and robust decisions that protect patient safety.
Recommendation 7 - A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient-reported outcomes measures.
Progress update - Ongoing. In 2021 to 2022, a scoping exercise was undertaken to determine how best to deliver this recommendation. This provided a significant amount of learning. They state that they concluded that, for England, expanding the coverage and breadth of existing registries will best deliver harmonised data collections that contain patient, device and outcome-level data. They have an target to increase registry coverage from 15% to 80% over the next 3 years. In parallel, the report notes that the Government are working with devolved governments to develop a UK-wide approach that will enable secure data sharing, system interoperability and UK-wide coverage, where appropriate to do so.
Recommendation 8 - Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests, and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
Progress update - Ongoing. The report states that they are currently piloting systems for doctors to declare their interests in NHS and independent settings across the UK. Full implementation will begin in 2023, subject to a successful review of the pilot systems. Once this system is in place for doctors, they note that they will then consider systems for other healthcare professionals. The report also notes that the Government has legislated through the Health and Care Act 2022 to enable the Secretary of State for Health and Social Care to make regulations requiring companies to publish or report information about their payments to the healthcare sector. The Government is reviewing the information gathered from stakeholders to develop plans on how best to deliver on the objectives of this recommendation.
Recommendation 9 - The government should immediately set up a taskforce to implement this review’s recommendations. Its first task should be to set out a timeline for their implementation.
Progress update - Not accepted. The Government did not accept recommendation 9. In this report they point to having instead established a Patient Reference Group to inform work to develop the 2021 government response. The Patient Reference Group published an independent report on their work in July 2021.
- Independent Medicines and Medical Devices Safety Review: A joint letter from the Association for Children Damaged by Hormone Pregnancy Tests, Sling The Mesh and In-Fact, 17 February 2022.
- Kath Sansom, 10 problems with NHS England’s specialist mesh centres, 3 October 2022.
- Patient Safety Spotlight interview with Marie Lyon, chair of the Association for Children Damaged by Hormone Pregnancy Tests, 22 February 2022.
- Patient Safety Learning, A year on from the Cumberlege Review: Initial reflections on the Government’s response, 26 July 2021.
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